Reducing Costs by Deprescribing Medications
Primary Purpose
Polypharmacy, Deprescribing, Adverse Drug Reaction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deprescribing Intervention
Usual Care
Sponsored by
About this trial
This is an interventional other trial for Polypharmacy
Eligibility Criteria
Inclusion Criteria:
- taking 10 or more regular medications
Exclusion Criteria:
- not receiving primary care at UT Physicians
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Deprescribing Intervention
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
Adverse Drug Reactions (ADR)
Patient-reported side effects and adverse events potentially attributable to medication, rated for the likelihood of ADR by an independent reviewer based on the Naranjo algorithm.
Adverse Drug Reactions
Patient-reported side effects and adverse events potentially attributable to medication, rated for the likelihood of ADR by an independent reviewer based on the Naranjo algorithm.
Adverse Drug Reactions
Patient-reported side effects and adverse events potentially attributable to medication, rated for the likelihood of ADR by an independent reviewer based on the Naranjo algorithm.
Healthcare Cost
Healthcare cost based on utilization of clinic visits, emergency room visits, and hospitalizations, based on patient report with specific costs obtained when possible from the Health Information Exchange.
Healthcare Cost
Healthcare cost based on utilization of clinic visits, emergency room visits, and hospitalizations, based on patient report with specific costs obtained when possible from the Health Information Exchange.
Healthcare Cost
Healthcare cost based on utilization of clinic visits, emergency room visits, and hospitalizations, based on patient report with specific costs obtained when possible from the Health Information Exchange.
Secondary Outcome Measures
Medication use
Number and name of each medication a participant is taking.
Medication cost
Average wholesale price of each medication taken by a participant, determined using reference software.
Medication cost
Average wholesale price of each medication taken by a participant, determined using reference software.
Medication cost
Average wholesale price of each medication taken by a participant, determined using reference software.
QOL
Quality of life as measured by the EQ5D scale.This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
QOL
Quality of life as measured by the EQ5D scale.This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
Full Information
NCT ID
NCT04553107
First Posted
September 11, 2020
Last Updated
November 21, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Blue Cross Blue Shield
1. Study Identification
Unique Protocol Identification Number
NCT04553107
Brief Title
Reducing Costs by Deprescribing Medications
Official Title
Reducing Healthcare Costs in Older Adults by Deprescribing Unnecessary, Harmful, and Costly Medications
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Blue Cross Blue Shield
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to implement a pharmacist-led deprescribing intervention for adults 65 and older taking 10 or more medications at University of Texas (UT) Physicians clinics and to assess the effect of the pharmacist intervention on the incidence of adverse drug reactions, emergency room visits, and hospitalizations as well as costs to the patient and to the healthcare system in adults 65 and older taking 10 or more medications treated at UT Physicians.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polypharmacy, Deprescribing, Adverse Drug Reaction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
419 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deprescribing Intervention
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Deprescribing Intervention
Intervention Description
An individualized deprescribing intervention will be created by a pharmacist working with a patient to identify harmful, costly, and unnecessary medications to be reduced. The intervention will include a plan and monitoring for up to 3 months to reduce medication use.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
The usual care arm will receive the current standard of care, which includes medication reconciliation by a clinic nurse at the time of their appointment. Nurses review all medications and answer medication-related questions, and refer medication questions to the healthcare provider for further discussion when necessary.
Primary Outcome Measure Information:
Title
Adverse Drug Reactions (ADR)
Description
Patient-reported side effects and adverse events potentially attributable to medication, rated for the likelihood of ADR by an independent reviewer based on the Naranjo algorithm.
Time Frame
3 months post enrollment
Title
Adverse Drug Reactions
Description
Patient-reported side effects and adverse events potentially attributable to medication, rated for the likelihood of ADR by an independent reviewer based on the Naranjo algorithm.
Time Frame
6 months post enrollment
Title
Adverse Drug Reactions
Description
Patient-reported side effects and adverse events potentially attributable to medication, rated for the likelihood of ADR by an independent reviewer based on the Naranjo algorithm.
Time Frame
12 months post enrollment
Title
Healthcare Cost
Description
Healthcare cost based on utilization of clinic visits, emergency room visits, and hospitalizations, based on patient report with specific costs obtained when possible from the Health Information Exchange.
Time Frame
3 months post enrollment
Title
Healthcare Cost
Description
Healthcare cost based on utilization of clinic visits, emergency room visits, and hospitalizations, based on patient report with specific costs obtained when possible from the Health Information Exchange.
Time Frame
6 months post enrollment
Title
Healthcare Cost
Description
Healthcare cost based on utilization of clinic visits, emergency room visits, and hospitalizations, based on patient report with specific costs obtained when possible from the Health Information Exchange.
Time Frame
12 months post enrollment
Secondary Outcome Measure Information:
Title
Medication use
Description
Number and name of each medication a participant is taking.
Time Frame
At enrollment
Title
Medication cost
Description
Average wholesale price of each medication taken by a participant, determined using reference software.
Time Frame
3 months post enrollment
Title
Medication cost
Description
Average wholesale price of each medication taken by a participant, determined using reference software.
Time Frame
6 months post enrollment
Title
Medication cost
Description
Average wholesale price of each medication taken by a participant, determined using reference software.
Time Frame
12 months post enrollment
Title
QOL
Description
Quality of life as measured by the EQ5D scale.This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
Time Frame
Baseline
Title
QOL
Description
Quality of life as measured by the EQ5D scale.This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.
Time Frame
12 months post enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- taking 10 or more regular medications
Exclusion Criteria:
not receiving primary care at UT Physicians
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly M Holmes, MD,MS
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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Reducing Costs by Deprescribing Medications
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